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CAR T-cell Therapy

Gene-Modified T Cells for Advanced Cancers

Phase 1 & 2

Waitlist Available

Led By Philip McCarthy, MD

Research Sponsored by Roswell Park Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with solid tumors meeting specific criteria for inoperable or metastatic melanoma, ovarian, primary peritoneal or fallopian tube carcinoma, synovial sarcoma, or other histologies

Patients must have adequate venous access for apheresis

Must not have

Requirement for systemic corticosteroids or concurrent immunosuppressive drugs

Uncontrolled intercurrent illness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the side effects and best dose of gene-modified T cells, given with or without decitabine, to treat patients with malignancies expressing cancer-testis antigens 1 (NY-ESO-1) gene that have spread to other places in the body (advanced).

Who is the study for?

This trial is for patients with advanced cancers like melanoma, ovarian, peritoneal or fallopian tube carcinoma, and synovial sarcoma that express the NY-ESO-1 gene. Participants need available tissue for testing or agree to a biopsy, have a caregiver nearby, meet medical criteria, use birth control, understand the study's nature and consent to it. They must not have brain metastases or severe autoimmune diseases.

What is being tested?

The trial tests gene-modified T cells with/without decitabine in treating advanced malignancies expressing NY-ESO-1. It aims to find out how well these treatments work and their best doses by modifying patients' T cells to target tumor cells better.

What are the potential side effects?

Potential side effects include immune reactions due to modified T cells targeting cancerous tissues; chemotherapy-related issues such as fatigue, nausea; risk of infection; possible adverse reaction from decitabine including blood disorders.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is inoperable or has spread and falls into one of the specified categories.

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My veins are suitable for apheresis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking steroids or drugs that affect my immune system.

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I do not have any unmanaged ongoing illnesses.

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I currently have an active infection.

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I have active brain tumors.

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I do not have dementia or significant changes in my mental status.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With Dose Limiting Toxicities

Number of Participants With Feasibility Concerns in Manufacturing of NY-ESO-1/ dnTGFbetaRII Engineered Cells

Secondary study objectives

Expression of the NY-ESO-1 T Cell Receptor (TCR) Transgenic Protein in Peripheral Blood Mononuclear Cells (PBMC)

Replication Competent Retrovirus (RCR)

Tumor Response (Complete and Partial Response)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort II (decitabine, cyclophosphamide, TCR/dnTGFbetaRII)Experimental Treatment5 Interventions

Patients undergo leukapheresis on day -6 and receive decitabine IV over 1 hour on days -6 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.

Group II: Cohort I (cyclophosphamide, TCR/dnTGFbetaRII)Experimental Treatment4 Interventions

Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Decitabine

2004

Completed Phase 3

~1720

Cyclophosphamide

2010

Completed Phase 4

~2310